Fusion Cage With Integrated Fixation And Insertion Features

ABSTRACT

A surgical implant system includes an implant and a fixation member for securing the implant to tissue. The implant and the fixation member together comprise a single monolithic structure. The implant includes an insertion instrument. The implant, the fixation member, and the insertion instrument together comprise a single monolithic structure and are constructed from a single material. The implant is monolithically connected to the fixation member at a first frangible connection and is monolithically connected to the insertion instrument at a second frangible connection. Each of the frangible connections can be broken when force is applied.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of the filing date of U.S.Provisional Patent Application No. 62/511,101 filed May 25, 2017, thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present inventions relate, in general, to surgical implant systemsand methods of implanting same. More particularly, the presentinventions relate to surgical implant systems including monolithicstructures having an implant, a fixation member, and/or an instrumentthat are frangibly connected for separation during a surgical procedure.

Surgical implants often include several components. The implant itselfmay be comprised of different pieces, and is often secured to adjacenttissue by one or more additional fixation elements, such as screws oranchors. In addition, one or more instruments are typically neededduring a surgical procedure to grasp and guide the implant and to placethe fixation element(s) to secure the implant. The many componentsneeded during one procedure can pose challenges for organization in theoperating room, sterilization to prevent infection, and accuracy andefficiency in properly handling and placing the implant and fixationelement(s) during a procedure. For instance, dropping or mishandlingsmaller screws can be a challenge during a procedure. This increasesmanufacturing costs as well as inventory of implants andinstrumentation.

There is a need in the art for a surgical implant system that overcomesthese drawbacks by simplifying surgical procedures and by making suchprocedures more efficient.

SUMMARY OF THE INVENTION

A first aspect of the present disclosure is a surgical implant systemthat includes an implant, a fixation member for securing the implant totissue, and an insertion instrument. The implant, the fixation member,and the insertion instrument together comprise a single monolithicstructure.

In other embodiments, the implant may be monolithically connected to thefixation member at a first frangible connection. The first frangibleconnection may be sheared through application of torque applied to thefixation member. The implant may be monolithically connected to theinsertion instrument at a second frangible connection. The secondfrangible connection may be broken through application of a forceapplied to the insertion instrument. The implant may be one of a spinalimplant, a cortical plate, and an acetabular cup.

The surgical implant system may be manufactured by three-dimensional(3D) printing. The surgical implant system may be manufactured byadditive layer manufacturing. The system may be constructed of a singlematerial.

A second aspect of the present disclosure is a surgical implant systemthat includes an implant and an insertion instrument. The implant andthe insertion instrument together comprise a single monolithicstructure.

In other embodiments, the system may be constructed of a singlematerial.

A third aspect of the present disclosure is a surgical implant systemthat includes an implant and a fixation member for securing the implantto tissue. The implant and the fixation member together comprise asingle monolithic structure.

In other embodiments, the surgical system may include an insertioninstrument. The implant, the fixation member, and the insertioninstrument together may comprise a single monolithic structure. Thesystem may be constructed of a single material. The implant may bemonolithically connected to the fixation member at a first frangibleconnection. The first frangible connection may be sheared throughapplication of torque applied to the fixation member. The implant may bemonolithically connected to the insertion instrument at a secondfrangible connection. The second frangible connection may be brokenthrough application of a force applied to the insertion instrument. Theimplant may be one of a spinal implant, a cortical plate, and anacetabular cup. The implant system may be manufactured by 3-D printing.The surgical system may be manufactured by additive layer manufacturing.

Another aspect of the present disclosure is a method of manufacturing asurgical implant system including constructing the surgical implantsystem by additive layer manufacturing to include an implant and afixation member for securing the implant to tissue. The implant ismonolithically connected to the fixation member at a first frangibleconnection, such that the implant and the fixation member togethercomprise a single monolithic structure.

In other embodiments, the method may include the step of constructingthe surgical implant to include an insertion instrument. The insertioninstrument may be monolithically connected to the implant at a secondfrangible connection, such that the implant, the fixation member, andthe insertion instrument together comprise a single monolithicstructure.

Another aspect of the present disclosure is a method of manufacturing asurgical implant system that includes 3-D printing the surgical implantsystem to include an implant, a fixation member for securing the implantto tissue, and an insertion instrument. The implant is monolithicallyconnected to the fixation member at a first frangible connection and theimplant is monolithically connected to the insertion instrument at asecond frangible connection, such that the implant, the fixation member,and the insertion instrument together comprise a single monolithicstructure.

In other embodiments of the method, the step of 3-D printing may include3-D printing the surgical implant system of a single material.

Yet another aspect of the present disclosure is a method ofmanufacturing a surgical implant system that includes constructing thesurgical implant system by additive layer manufacturing to include animplant, a fixation member for securing the implant to tissue, and aninsertion instrument. The implant is monolithically connected to thefixation member at a first frangible connection and the implant ismonolithically connected to the insertion instrument at a secondfrangible connection, such that that the implant, the fixation member,and the insertion instrument together comprise a single monolithicstructure.

In other embodiments of the method, the step of constructing may includeconstructing the surgical implant system of a single material.

Yet another aspect of the present disclosure is a method of inserting asurgical implant system including implanting a single monolithicstructure including an implant, a fixation member for securing theimplant to tissue, and an insertion instrument. The implant ismonolithically connected to the fixation member at a first frangibleconnection and the implant is monolithically connected to the insertioninstrument at a second frangible connection. The method further includesapplying a force to the fixation member to break the first frangibleconnection and applying a force to the insertion instrument to break thesecond frangible connection.

Another aspect of the present disclosure is a device for intervertebraldisc repair that includes a spacer and a fixation member. The fixationmember has an initial condition in which the spacer and the fixationmember are monolithically connected and an operative condition in whichthe fixation member and spacer are separate and distinct.

In other embodiments, the fixation member may have a screw having acentral axis. The spacer may define an aperture for receiving the screw,the aperture having a perimeter at a location about a central axis ofthe aperture that is fully enclosed within the spacer. The central axisof the screw and the central axis of the aperture may extend through ananterior surface of the spacer at a non-perpendicular angle. The spacermay further define a second aperture for receiving a second screw, thesecond aperture defining a perimeter at a location about a central axisof the second aperture that is fully enclosed within the spacer. Thesecond aperture may have a central axis. The central axis of the screwand the central axis of the second aperture may extend through ananterior surface of the spacer at a second non-perpendicular angle, thefirst and second non-perpendicular angles being different. The spacermay include a channel for receiving an anchor, the channel being adovetail slot extending along a superior or an inferior surface of thespacer. The channel may extend between and intersect both an anteriorsurface and a posterior surface of the spacer. A perimeter of thechannel about a central axis of the channel may not be fully enclosedwithin the spacer at a location about the central axis of the channel.The fixation member may be an anchor blade. The blade may be positionedrelatively further from the posterior surface of the spacer when theblade is in the initial condition, and the blade may be positionedrelatively closer to the posterior surface when the blade is in theoperative condition.

Yet another aspect of the present disclosure is an intervertebral systemincluding a spacer having a recess for receiving a bone anchor and abone anchor frangibly coupled to the spacer and being movable relativeto the spacer. The bone anchor has an initial position in which the boneanchor is positioned with a distal end of the anchor in the recess ofthe spacer and an operative position in which the anchor is positionedwith at least a proximal end of the anchor in the recess. In the initialposition the bone anchor and the spacer are monolithically connected.

In other embodiments, movement of the bone anchor from the initialposition to the operative position may engage the bone with the boneanchor to secure the spacer to an adjacent vertebra. The movement mayinclude torque of the bone anchor.

Another aspect of the present disclosure is a device for intervertebralrepair including a spacer having a posterior surface and an anteriorsurface and a bone anchor frangibly coupled to the spacer. The boneanchor has an initial position in which the bone anchor is relativelyfar from the posterior surface of the spacer and an operative positionin which the bone anchor is relatively near to the posterior surface ofthe spacer. In the initial position the bone anchor is monolithicallyconnection with the spacer. The device also includes an insertioninstrument that has an initial condition in which the instrument ismonolithically connected with the spacer and an operative condition inwhich the instrument is separate and distinct from the spacer.

In other embodiments, in the initial condition the insertion instrumentmay be adapted to stabilize the device and/or drive the device into adisc space.

Yet another aspect of the present disclosure is a bone plating systemincluding a plate having a recess for receiving a bone anchor and afixation member movable relative to the plate. The fixation member hasan initial position in which the fixation member is positioned with adistal end thereof in the recess of the plate and an operative positionin which the fixation member is positioned with at least a proximal endthereof in the recess. The system includes an insertion instrument thathas an initial condition in which the instrument is monolithicallyconnected with the plate and an operative condition in which theinstrument is separate and distinct from the plate. In the initialposition, the fixation member and plate are monolithically connected.

Another aspect of the present disclosure is a device for intervertebralrepair including a spacer having an anterior surface and an insertioninstrument. The insertion instrument is frangibly coupled to theanterior surface of the spacer and has an initial condition in which theinstrument is monolithically connected with the spacer and an operativecondition in which the instrument is separate and distinct from thespacer.

Another aspect of the present disclosure is a method of using anintervertebral device including inserting the device into disc space,the device including a spacer, a bone anchor monolithically coupled tothe spacer, and an insertion instrument monolithically coupled to thespace; moving the bone anchor relative to the spacer, such that the boneanchor and the spacer become separate and distinct pieces; and bendingthe insertion instrument such that it breaks apart from the spacer.

In other embodiments, the step of moving the bone anchor may engage thebone anchor to an adjacent vertebra. The step of moving the bone anchormay include rotating the anchor. The step of moving the anchor mayinclude driving the anchor distally. The method may include the step ofremoving the insertion instrument from a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the presentinvention(s) and of the various advantages thereof can be realized byreference to the following detailed description in which reference ismade to the accompanying drawings in which:

FIGS. 1-5 are front perspective, top perspective, front perspective,enlarged front perspective, and sectional front perspective views,respectively, of an intervertebral implant system according to anembodiment of the present invention;

FIG. 6 is a front perspective view of an intervertebral implant systemaccording to another embodiment of the present invention;

FIG. 7 is an enlarged front perspective view of a portion of theintervertebral implant system of FIG. 4;

FIGS. 8-11 are front perspective, side perspective, rear elevational,and enlarged front elevational views, respectively, of an intervertebralimplant system according to another embodiment of the present invention;

FIG. 12 is a top perspective view of a bone plate system according toanother embodiment of the present invention; and

FIGS. 13-15 are front perspective, side perspective, and sectional sideviews, respectively, of an acetabular implant system according to anembodiment of the present invention.

DETAILED DESCRIPTION

In describing certain aspects of the present invention(s), specificterminology will be used for the sake of clarity. However, theinvention(s) is not intended to be limited to any specific terms usedherein, and it is to be understood that each specific term includes alltechnical equivalents, which operate in a similar manner to accomplish asimilar purpose. In the drawings and in the description which follows,the term “proximal” refers to the end of the fixation members andinstrumentation, or portion thereof, which is closest to the operator inuse, while the term “distal” refers to the end of the fixation membersand instrumentation, or portion thereof, which is farthest from theoperator in use.

Referring to FIGS. 1-5, an intervertebral implant system 100 accordingto an embodiment of the present invention includes a monolithic devicecast as a single piece including a spacer 110 frangibly connected withfixation members or screws 125 and an insertion instrument 135. System100, including all components thereof, is made of a single material. Asystem in accordance with the present inventions can include a singlefixation member or two or more fixation members depending on aparticular procedure and/or the configuration of the associated implant.Although initially constructed as a single, continuous structure,implant system 100 includes frangible connections between spacer 110 andfixation members 125 and between spacer 110 and instrument 130. Themonolithic connection among the different components can be disconnectedor broken after spacer 110 is positioned in an intervertebral disc spaceof the spine. While it will be discussed below that system 100 isproduced through additive layer manufacturing (ALM), i.e. 3D printing,it is understood that the single, continuous or monolithic construct iscreated upon completion of the ALM process. The monolithic constructionof system 100 is completed during a single process, which differentiatesit from processes of separately manufacturing and later welding togetherthe different components of system 100. Alternate systems in accordancewith the present inventions can include a monolithic device cast as asingle piece including a spacer 110 frangibly connected with fixationmembers or screws 125 and omitting an instrument. Systems can alsoinclude a monolithic device cast as a single piece including a spacer110 frangibly connected with an insertion instrument 135 and omittingfixation members.

As described more thoroughly below, implant system 100 is manufacturedas a one-piece, integral construct with integrated fixationanchors/screws as well as integrated instrumentation to facilitateimplantation. The preferred method of manufacturing system 100 is byutilizing 3D printing technology, which allows system 100 to be mademonolithically with all features and components built into system 100from the start. This improves handling of system 100 during implantationand can streamline the surgical procedure to make it more efficient.Notably, the initial construction and positioning of the fixationanchors/screws in system 100 eliminates the need for guides, such asscrew guides, since the fixation elements are already in place forinsertion once the main implant is finally seated. System 100 is fullyready to implant immediately out of its packaging, which minimizes stepsfor the surgeon and is designed to reduce complexity and increaseoperational efficiency. These benefits extend to all of the presentembodiments, as well as to other types of surgical implant systems ascontemplated by the present disclosure.

Spacer 110 includes a top or superior bone-contacting surface 111 and abottom or inferior surface 112, a posterior or leading surface 115, ananterior or trailing surface 116 opposite leading surface 115, andlateral surfaces 114 extending between the leading and trailing surfaces115, 116. In the illustrated embodiment, spacer 110 has a generallyrounded, oblong shape with lateral surfaces 114 being rounded.Alternatively, spacer 110 may be generally, square, rectangular, kidney,oval, circular, or other geometric shape in the superior view. Top andbottom surfaces or endplates 111, 112 may be flat, concave, convex, orany other shape in the anterior or lateral views and may include teethor ridges for more secure placement against endplates of the adjacentvertebrae. Endplates 111, 112 can be porous to optimize bonegrowth/fusion. In particular, in a lateral view, top and bottom sides111, 112 may be curved or angled to give spacer 110 a lordotic shape.Hyperlordotic and double taper implants are also contemplated.

Spacer 110 further defines opening 120 extending from top surface 111 tobottom surface 112. Opening 120 has a generally rounded, oblong shapeand is surrounded by inner surface 122. However, in other examples,opening 120 may have any shape or may comprise multiple openings.Opening 120 may allow for receipt of bone in-growth material, such asbone chips, autograft, allograft, Demineralized Bone Matrix (DBM), orsynthetics.

Spacer 110 further includes two screws 125 positioned in respectiveholes 126, the screws and holes each extending from trailing surface 116to inner surface 122 and being spaced apart. Holes 126 and screws 125each extend about a central axis that forms a non-perpendicular anglewith trailing surface 116. The angle of the screws and holes can vary asdesired, and may be prepared such that the screws can reach the adjacentvertebral endplate to fix spacer 110 to the adjacent vertebra. Each hole126 may be angled in a different direction from the other hole, and eachscrew 125 may be angled in a different direction from the other screw.However, in other examples, holes 126 may also extend about a centralaxis that is substantially perpendicular to trailing surface 116. Asshown in FIG. 3, it is preferable that screws 125 are angled in oppositedirections to engage both superior and inferior positioned vertebrae.Although the illustrated embodiment has two holes 126 and screws 125, inother arrangements there may be more or less of the holes and screws.

As best shown in FIG. 2, screws 125 are initially monolithicallyconnected with spacer 110 and positioned such that the distal portion ofthe screw extends through inner surface 122, a portion of the screwshaft being enclosed within hole 126 of spacer 110, and the head and aportion of the shaft is positioned anteriorly external to trailingsurface 116. During a 3D printing procedure, spacer 110 and screws 125are manufactured simultaneously with at least one frangible connection129 therebetween. This connection can be a relatively thin layer of thematerial of spacer 110 and screws 125 that bridges or connects adjacentlocations between spacer 110 and screws 125. For example, as best shownin FIGS. 3-4, the frangible connection 129 is a radial flange of thematerial extending from the shaft or a thread on the shaft of screw 125to a surface of hole 126. This flange can be perpendicular to the screwaxis or angled thereto. Of course, multiple connections 129 can beutilized and spaced apart about the circumference of screw 125. A singleconnection 129 can also be employed. In other embodiments, an annularflange between spacer 110 and screws 125 can be provided via thematerial during 3D printing. In each case regardless of the geometry andlocation of the frangible connection, the material at the connection canbe selectively constructed to break or shear upon a force applied to oneof spacer 110 and screws 125. That is, screws 125 can be torqued toadvance them further into holes 126. As screw 125 is torqued, thefrangible connection between screw 125 and spacer 110 breaks such thatscrew 125 becomes a separate piece from spacer 110 and screw 125 isthereafter inserted further into hole 126 and ultimately intocommunication with an adjacent vertebra.

In the illustrated embodiment, there are two threaded screws 125, angledin opposite directions; however, in other examples there may be more orless of screws 125 and the screws may be angled in differentconfigurations. Screws 125 may include variable and/or fixed anglescrews. Further, screws 125 may include self-drilling and/orself-tapping features to facilitate and minimize screw-hole preparation.

Spacer 110 further includes insertion instrumentation 130. Instrument130 includes shaft 131 extending from a distal end 133 to a proximal end134. Distal end 133 of shaft 131 is monolithically connected with andcoupled to trailing surface 116 in a manner similar to the connectionbetween spacer 110 and screws 125. The monolithic construction ofinstrument 130 with spacer 110 is strong in both compression and tensionforces. That is, the interface between instrument 130 and spacer 110 issuch that it can withstand forces applied by a user during a surgicalprocedure without breaking. As instrument 130 is bent with respect tospacer 110, it breaks off from spacer 110 and can be removed from thepatient. Distal end 133 may be tapered, as in FIG. 2, or it may bestraight. The taper can be configured to facilitate the ultimatebreakage between instrument 130 and spacer 110. In some cases, the taperor the connection in general can be manufactured to be stronger in someplanes as opposed to others. That is, it may be easier to bendinstrument 130 with respect to spacer 110 at particular angles.

Shaft 131 extends generally orthogonally to trailing surface 116 andextends in an anterior direction from the spacer 110. Further,instrument 130 extends generally parallel to upper and lower surfaces111, 112, but in other examples, the instrument may extend in an angleddirection, either superiorly, inferiorly, or laterally to spacer 110.Proximal end 134 of shaft 131 may include raised portion 136 for easiergripping. Raised portion 136 may further include an attachment mechanismto attach to a separate handle such as a quick connect handle (notshown), if further length of insertion instrument 130 is required duringa procedure. However, in other examples, shaft 131 may be flat and maynot include a raised portion. In some embodiments, instrument 130 may beused as a driver to drive one or more of screws 125 into their fullyinserted positions after instrument 130 is separated from spacer 130.

FIGS. 6-7 depict an intervertebral implant system 100′ according toanother embodiment of the present invention. Implant system 100′ hassimilar features to those described above in connection with implantsystem 100. Screws 125′ are initially monolithically connected to spacer110′ by frangible connection 129′ that is constructed to break or shearupon a force applied to one of spacer 110′ and screws 125′. In theillustrated embodiment, frangible connection 129′ is similar tofrangible connection 129 of spacer 110 and is a radial flange of thematerial extending from the shaft or a thread on the shaft of screw 125′to a surface of hole 126′. In other arrangements, the frangibleconnection 129′ can be configured with different geometries, includingan annular flange, and one or more connections 129′ can be employed.

Screws 125′ each include a locking mechanism 127′ to secure the screwswithin spacer 110′ after implantation. As best shown in FIG. 6, lockingmechanism 127′ is located on the head of each screw 125′ and includesflange 128′ extending further radially outward from the rest of the headof screw 125′. Flange 128′ has an outwardly extending protrusion which,when it contacts an inner surface of hole 126′, causes flange 128′ toflex inward toward screw to produce a friction fit between the head ofscrew 125 and hole 126′. Holes 126′ may also include a groove (notshown) for flange 128′ to snap into. Flange 128′ is provided to inhibitbackout of screw 125′ once it is inserted into spacer 110′. Other typesof known anti-backout mechanisms, such as split rings, spring bars,washers, rotatable cover plates, etc., can also be used. Snap fits,cover plates, and/or other compression technology known in the art maybe used.

A method of implanting intervertebral implant systems 100, 100′ in thelumbar spine from an anterior surgical approach will now be describedwith reference to system 100. At least a portion of an intervertebraldisc between adjacent vertebrae is removed using tools and techniquesknown in the art. Intervertebral implant system 100 is provided in asterile kit. Once removed from the packaging, instrument 130 isconnected with a quick connect handle. In some instances, a tube can beinserted over instrument 130 for added stability during insertion.Spacer 110 and screws 125 are then inserted into the prepared disc spaceusing insertion instrument 130. This can include impacting a proximalend of instrument 130. Once spacer 110 is located in the disc space, thesurgeon can use instrument 130 to manipulate and stabilize spacer 110 inthe desired location.

The surgeon then torques each of screws 125 with a driver, such as bymanually driving the screw or using a power driver, such that attachmentbetween the screws and spacer 110 is sheared. Screws 125 continue to betorqued and rotated into engagement with the respective vertebrae.Because the screws are already angled within spacer 110, the screws arepositioned having the appropriate and correct trajectory into the bone.After the implant 100 is secured within the bone, the surgeon may thencantilever and break off instrument 130. Breaking off instrument 130 mayallow for a flat surface, such that the break is clean without leavingany sharp edges. Instrument 130 is then removed from the patient. Incertain embodiments, removal of instrument 130 can be done at an earlierstage so that it can be used as a driver for one or more screws 125. Aseparate mechanism for preventing backing out of screws 125 may then beattached to the implant, if desired.

It will be understood that the same or similar methods may be employedto install the implant system 100 at any level of the spine, and fromany surgical approach, including lateral, without departing from thescope of the present invention. More specifically, it is contemplatedthat implant system 100 may be implanted from an anterior, posterior,posterior-lateral, lateral, or other surgical approach.

FIGS. 8-11 depict an intervertebral implant system 200 according to anembodiment of the present invention. Implant system 200 includes spacer210, fixation members or anchor blades 245 and insertion instrument 230.Spacer 210 includes top and bottom surfaces 211, 212, respectively,leading surface 215, a trailing surface 216 opposite leading surface215, and lateral surfaces 214 extending between the leading and trailingsides 215, 216. In the illustrated embodiment, spacer 210 has agenerally rounded, oblong shape with lateral surfaces 214 being rounded.Alternatively, spacer 210 may be generally, square, rectangular, kidney,oval, circular, or other geometric shape in the superior view. Top andbottom surfaces 211, 212 may be flat, concave, convex, or any othershape in the anterior or lateral views and may include teeth or ridgesfor more secure placement against endplates of the adjacent vertebrae.In particular, in a lateral view, top and bottom surfaces 211, 212 maybe curved or angled to give spacer 210 a lordotic shape.

Spacer 210 further includes channels or tracks 250 that extend acrossspacer 210 between and intersect with both leading side 214 and trailingside 216. As shown in FIGS. 8-9, channels 250 are dovetail slots thatare formed in spacer 210 in a truncated I-beam shape. However, in otherexamples, the channels 250 may have a variety of shapes, includingcircular, rectangular, keyhole, T-shaped, etc. Each channel ispreferably configured to have an enlarged profile away from the adjacentsurface so that an anchor disposed therein can be secured from migratingout of that channel toward the surface. Each dovetail slot is configuredto slidably engage with a mating feature on an anchor 245, described indetail below. Spacer 210 includes two channels, one channel 250 that isopen toward top surface 211 of the spacer and extends across top surface211, and one channel 250 that is open toward bottom surface 212 of thespacer and extends across bottom side 212. Although in other examples,there may be more or less of channels 250.

As shown in FIG. 8, each channel 250 may extend about a central axisthat is perpendicular to leading surface 214. However, in otherexamples, the central axis of the channels may be angled, i.e. forms anon-perpendicular angle, with respect to leading surface 214. Channels250 may extend across top and bottom surfaces 211, 112 along an axisthat extends straight through spacer 210 from trailing surface 216 toleading surface 214. Although, in other examples, the channels may beconfigured to extend from trailing surface 216 to leading surface 214 ina variety of angles. Further, each channel 250 may have a perimeterabout its central axis that is not fully enclosed within spacer 210 atany location along its central axis so that it is open in the superioror inferior direction, as the case may be.

Spacer 210 further includes openings 220, 221 extending from top surface211 to bottom surface 212 and positioned on lateral sides of channels250. Openings 220, 221 are surrounded by inner surfaces 222 and areshaped as semi-ovals; however, in other examples, the openings may beshaped as generally circular, rectangular, or any other shape. Openings220, 221 may allow for receipt of bone in-growth material. Additionally,instrument 230 is similar to instrument 130 and functions in the samemanner.

Anchor blades 245 are used as a fixation method with spacer 210. Anchor245 may include an interconnection portion 255 extending between leadingend and trailing ends 246, 248. Interconnection portion 255 is shapedand sized to matingly attach with the channels 250 of spacer 210. In thepresent embodiment, the interconnection portion is a dovetail beam 255that can slidably attach to the plates and spacers.

Anchor 245 can include a stop feature, such as a flange, near trailingend 248 to prevent the anchor from migrating too far posteriorly intoprosthesis 210 after implantation. Anchor 245 can further include alocking feature, such as a flexible tab disposed near the trailing end248 of the dovetail beam 255, to prevent the anchor from migratinganteriorly after implantation. The stop feature and the flexible tab cancooperate with spacer 210 to maintain anchor 255 in its implantedposition in the spacer. Anchor 245 also includes a fixation portion 260that secures anchor 245 to an adjacent vertebra. Fixation plate 260 maybe sharpened around a portion of its profile to create a cutting edge tocut through bone. The anchors and other aspects of system 200 arefurther disclosed in U.S. Pat. No. 8,349,015, issued on Jan. 8, 2013,and titled “Intervertebral Implant With Integrated Fixation,” thedisclosure of which is hereby incorporated by reference herein.

As shown in FIGS. 8-11, anchors 245 are each positioned with a portionof interconnection portion 255 inserted in and frangibly attached tochannel 250. This can be done during a 3D printing procedure byincluding at least one frangible connection 229 between anchor 245 andspacer 210. In the illustrated embodiment, frangible connection 229 is aflange of the material extending from interconnection portion 255 tochannel 250 that bridges the anchor and the spacer. This flange can beperpendicular to the interconnection portion axis or angled thereto.Multiple connections 229 can be utilized and spaced apart about theinterconnection portion 255. However, a single connection 229 can alsobe employed. Once the frangible connection is broken between spacer 210and interconnection portion 255, the interconnection portion can slidewithin channel 250 without interference. The surface area of theconnection can be small enough so that the connection shears upon aforce applied to the proximal end of anchor 245, but large enough towithstand typical forces that may be applied, purposefully orincidentally, to anchor 245 during initial insertion of spacer 210. Inother arrangements, the frangible connection can be between the bottomsurface of leading end 246 of interconnection portion 255 and theadjacent bottom surface of channel 250.

After inserting the implant system into the prepared disc space, anchors245 can be driven into the bone, such as by manually driving anchors 245or using a pneumatic driver, such that the blade slides into positionfurther distally within channel 250 and the monolithic attachment of theanchors with spacer 210 is broken. As a result, a proximal portion neartrailing end 248 of anchor 245 is closer to trailing side 216 and withinchannel 250.

Although described above with reference to illustrated anchor 245, otherembodiments of anchor blades work in conjunction with implant system200. Any sort of staple, blade, or anchor that is eventually insertedinto connection with spacer 210 and one or more adjacent vertebrae canbe 3D printed and frangibly connected in the manner discussed above.Additionally, a spacer may be configured such that it includes bothscrew fixation members and blade fixation members. In this manner, aspacer similar to spacer 210 may include screws similar to screws 125 orscrews 125′. The screws may be located on either side of instrument 230on trailing surface 216. Further, the screws may be angled, such thatone screw extends superiorly and the other screw extends inferiorly.Both the blades and screws may be formed monolithically with the spaceror one fixation mechanism, such as one of the screws and blades, may bemonolithic, while the spacer is designed to allow for insertion of thenon-monolithic, standalone fixation component.

Implant systems 100, 100′, and 200, as well as others according to thepresent inventions, may include one or more radiographic markers on thetop surfaces of spacers 110, 110′, and 210 (not shown). Additionally,the spacers may include serrations on various surfaces, i.e. top andbottom surfaces, to allow for fixation with adjacent vertebrae.

Although shown as anterior implants, intervertebral systems 100, 100′,210 may be configured and dimensioned for lateral spinal surgery. Inthis manner, the system, in particular spacers 110, 110′, 210 may havedimensions that are greater in the medial-lateral direction and lesserin the anterior-posterior direction as compared to spacer 110, 110′,210.

In other embodiments, spacers 110, 110′, 210 may include an attachmentmechanism to allow for attachment of a retaining mechanism or plate attrailing surface 116. The retaining mechanism may include clips,positioned for example on a top surface, bottom surface, and/or lateralsurfaces to attach to fit into recesses in corresponding locations onspacer 100. Such retaining mechanisms are disclosed in U.S. Pat. No.9,480,577, issued on Nov. 1, 2016, and titled “Retaining Mechanism,Implant, and Tool,” and U.S. Application No. 62/478,162, filed on Mar.29, 2017, and titled “Spinal Implant System,” the disclosures of both ofwhich are hereby incorporated by reference herein.

A method of implanting intervertebral implant system 200 in the lumbarspine from an anterior surgical approach includes first removing atleast a portion of an intervertebral disc between adjacent vertebrae.Intervertebral implant system 200, provided in a sterile kit andincluding spacer 210, anchor blades 245, and instrument 230, is theninserted into the prepared disc space using insertion instrument 230 formanipulation. Once spacer 210 is in the disc space, the surgeon can useinstrument 230 to stabilize the spacer 210 in the desired location. Thesurgeon then drives anchor blades 245 in a posterior direction to engagethe adjacent vertebrae using guiding instruments, which can be equippedto handle impaction during the insertion. In doing so, the attachmentbetween anchors 245 and spacer 210 is sheared and anchors 245 are movedinto full connection with spacer 210 and the respective vertebrae. Afterimplant 200 is secured within the bone, the surgeon may then break offinstrument 230. Breaking off instrument 230 may allow for a flatsurface, such that the break is clean. Instrument 230 is then removedfrom the patient. A mechanism for preventing backing out of anchors 245,such as a cover plate, may optionally be attached to implant.

FIG. 12 shows a spinal fusion plate system 300 according to anembodiment of the invention that may be used to stabilize or fusevertebral bodies of the spine. The system is configured to span acrossand fixate at least two vertebrae of the spine. The system comprises aplate 315 having screws 325 extending into the plate and instrumentation330. Plate 315 includes an upper surface or anterior surface 321 facingthe patient's soft tissue when installed and a lower surface orposterior surface 322 facing the vertebral bodies to be immobilized. Theupper surface 321 and lower surface 322 are interconnected by curvedside walls and end walls to form a generally rectangular shape that issymmetrical about a midline. The gently curved structure of plate 315complements the natural curved structure of the vertebral bodies andlordotic curvature of the spine. The corners of the plate are rounded toreduce irritation of the surrounding tissue. Plate 315 has a low profileto minimally impinge on adjacent tissue.

Plate system 300 further includes screws 325 similar to screws 125 andincluding a locking feature 327 similar to locking feature 127′. Screws325 are initially monolithically connected to spacer 310 by frangibleconnection 329, similar to frangible connection 129 of spacer 110.Connection 329 is constructed such that it can break or shear upon aforce applied to one of spacer 310 and screws 325. In the illustratedembodiment, there are multiple connections 329 each extending from screw325 to an inner surface of hole 326. In other arrangements, more or lessfrangible connections having the same or different configurations can beemployed, as described above.

In the illustrated embodiment, four screws 325 are positioned withinholes 326, the screws and holes extending from upper surface 321 tolower surface 322. Screws 325 may be fixed and/or variable angle screws.Screws 325 are spaced apart and each one is positioned near a curvedcorner of plate 315. Opening 320 is positioned generally centrally onplate 315 and extends from upper surface 321 to lower surface 322.Opening 320 reduces the overall weight of plate 315 and provides avisualization pathway to monitor bone graft progress between thevertebral bodies. Screws 325 are frangibly connected with plate 310 in amanner similar to screws 125 with spacer 120.

Plate system 300 further includes instrument 330 similar to instrument130 of implant system 100. The frangible connection between plate 310and instrument 330 is similar to that of spacer 110 and instrument 130.Instrument 330 is positioned on upper surface 321 and extends anteriorlyaway from the upper surface. Instrument 330 may be positioned in betweentwo screws 325 or in any location on plate 300 where it can be used formanipulation of plate 300 by a user without interfering with themanipulation of screws 325.

A method of implanting bone plate system 300 includes placing plate 310adjacent to a vertebral column using instrument 330 as a guide and/orhandle for insertion. The placement of the plate 310 relative to thevertebral bone in a patient may be determined based on a pre-operativeexamination of the patient's spine using non-invasive imaging techniquesknown in the art. Any additional preparation may be done around thedesired vertebrae prior to positioning plate 310. Once plate 310 isappropriately positioned, screws 325 are torqued, such that theattachment of screws 325 with plate 310 is sheared. Screws 325 arefurther torqued to engage the bone. After plate 310 is secured,instrument 330 is broken off from the implant.

FIGS. 13-15 depict a prosthetic acetabular cup implant system 400according to an embodiment of the present invention. Implant system 400includes an acetabular cup 410 and screw 425 positioned in hole 426.Screw 425 is frangibly connected with cup 410 by frangible connections429 in a manner similar to screws 125 with spacer 110. In theillustrated embodiment, each frangible connection 429 is radial flangeof the material extending from the shaft or a thread on the shaft ofscrew 425 to a surface of hole 426. The flange can be perpendicular tothe screw axis or angled thereto. Although shown as having more than oneconnection 429, the system 400 may include a single connection, such asa single annular connection.

Acetabular cup 410 is a part-spherical cup adapted for location in anacetabulum and having a rounded outer surface 415 and an inner bearingsurface 417 to receive a bearing liner and a part-spherical ball headwhich can be attached to a prosthetic stem for location in a femur.Acetabular cup further defines an opening 420 due to the semi-sphericalshape of the cup. Acetabular cup 410 further includes flat surface orrim 427 extending between outer surface 415 and inner surface 417.

Hole 426 and screw 425 extend along a central axis from inner surface417 to outer surface 415. In the illustrated embodiment, there is onescrew 425 located generally centrally at a midpoint of acetabular cup410. Screw 425 is formed monolithically with acetabular cup 410. Screw425 is initially positioned such that a portion of the screw shaft isenclosed within acetabular cup 410 and the tip extends proximally fromthe acetabular cup. Further, the head of the screw is positioned withinopening 420.

In the illustrated embodiment, screw 425 is similar to screw 125, butimplant system 400 can also include a screw similar to screws 125′, inwhich a locking mechanism is including within the screw and/or hole tosecure the screw within acetabular cup 410. Additionally, although theillustrated embodiment there is only one screw 425, the system mayinclude multiple screws 425 and holes 426 spaced apart on acetabular cup410. It is also contemplated that an instrument like instrument 130 beconnected with a portion of cup 410, such as rim 427 so as not tointerfere with bearing surface 417. However, this highlights thatsystems in accordance with the present invention can be provided withjust an implant and fixation member(s), and without an insertioninstrument. Likewise, an insertion instrument can be provided in asystem with an implant but without fixation members if none areapplicable or desired.

A method of implanting hip implant system 400 includes preparing anacetabulum for insertion of implant system 400. Cup 410 is then insertedinto the patient, and screw 425 is torqued. The torque shears theattachment of screw 425 with cup 410. Screw 425 is torqued further suchthat it engages the bone to provide securement of the implant to thebone.

Implant systems in accordance with the present inventions are formedusing three-dimensional (3D) printing to produce a monolithic structurecomprised of a spacer, one or more fixation members, and/or an insertioninstrument, the fixation members and instrument being frangibly coupledto the spacer. The implant system does not experience any additionalfixation process to provide for the monolithic construction and as suchthe monolithic connection is not the result of welding, fusing, cement,or any similar process beyond the particulars of the ALM process usedduring construction. The systems can be comprised of a porous metal orcan have a solid internal core with a porous metal surface such as aporous titanium alloy, including Tritanium® by Howmedica OsteonicsCorporation. The implant systems may be comprised of metal, such astitanium, ceramic, glass, polymer, or any other material known for usein the human body and capable of utilization in a 3D printing technique.The implant systems may also comprise one or more surface treatments toencourage bony attachment, such as porous coating, plasma spray coating,hydroxyapatite, or tricalcium phosphate.

In preferred arrangements, any of the present implants systems can beformed, at least in part, in a layer-by layer fashion using an additivelayer manufacturing (ALM), i.e. 3D printing, process using a high energybeam, such as a laser beam or an electron beam. Such ALM processes maybe but are not limited to being powder-bed based processes including butnot limited to selective laser sintering (SLS), selective laser melting(SLM), and electron beam melting (EBM), as disclosed in U.S. Pat. Nos.7,537,664 and 9,456,901, the disclosures of each of which are herebyincorporated by reference herein, or other ALM processes such as but notlimited to powder-fed based processes including but not limited to fusedfilament fabrication (FFF), e.g., fused deposition modeling (FDM).

The implants and systems may be constructed of porous geometries whichhave been digitally modeled using unit cells, as further described inU.S. Pat. Nos. 9,180,010 and 9,135,374, the disclosures of each of whichare hereby incorporated by reference herein. A first layer or portion ofa layer of powder is deposited and then scanned with a high energy beamto create a portion of a plurality of predetermined unit cells.Successive layers of powder are then deposited onto previous layers ofthe powder and also may be individually scanned. The scanning anddepositing of successive layers of the powder continues the buildingprocess of the predetermined porous geometries. As disclosed herein, bycontinuing the building process refers not only to a continuation of aporous geometry from a previous layer but also a beginning of a newporous geometry as well as the completion of a porous geometry. Theporous geometries of the formed porous layers may define pores that maybe interconnecting to provide an interconnected porosity. Of course,implants can also be made to be solid with or without porous portions.

In accordance with the present teachings, frangible fixation membersand/or insertion instruments may be used for other prosthetic implantsthroughout the body. The present invention is not limited to anyparticular type of implant and is not limited to surgical applications.For example, it is contemplated that the present invention can beimplemented in different spinal implants, such as the implants disclosedin U.S. application Ser. No. 14/994,749, filed on Jan. 13, 2016, andtitled “Spinal Implant with Porous and Solid Surfaces,” the disclosureof which is hereby incorporated by reference herein. Moreover, otherareas and uses may include unicompartmental knee replacement implants,bicompartmental knee replacement implants, tricompartmental kneereplacement implants, total knee replacement implants, patellofemoralreplacement implants, shoulder implants, hip implants, cortical andspinal plates, base plates, etc. An implant in accordance with thepresent application can be a patient-specific implant generated from CADfiles, for example, so that it is unique for a particular patient andapplication. Other nonsurgical applications are also contemplated. Forexample, an L bracket may be monolithically formed with a screw usingadditive layering manufacturing, as described above. This arrangementcan be used to insert a screw into a wall. The screw may be frangiblyconnected to the L bracket such that torqueing the screw breaks theconnection with the L bracket.

Systems in accordance with the present invention allow pre-packaging ofthe entire monolithic implant system, which can reduce manufacturingcost as well as inventory of implants and instruments as part of aninstrumented fusion surgery. A system can be offered pre-packaged as aset in a sterile package. This allows the packaged implant system,provided in a blister package for example, to be supplied to anoperating room and opened immediately prior to use in a surgicalprocedure.

Furthermore, although the invention disclosed herein has been describedwith reference to particular features, it is to be understood that thesefeatures are merely illustrative of the principles and applications ofthe present invention. It is therefore to be understood that numerousmodifications, including changes in the sizes of the various featuresdescribed herein, may be made to the illustrative embodiments and thatother arrangements may be devised without departing from the spirit andscope of the present invention. In this regard, the present inventionencompasses numerous additional features in addition to those specificfeatures set forth in the claims below.

1. A surgical implant system comprising: an implant; and a fixationmember for securing the implant to tissue, wherein the implant and thefixation member together comprise a single monolithic structure.
 2. Thesurgical implant system of claim 1, further comprising an insertioninstrument, wherein the implant, the fixation member, and the insertioninstrument together comprise a single monolithic structure.
 3. Thesurgical implant system of claim 2, wherein the system is constructed ofa single material.
 4. The surgical implant system of claim 2, whereinthe implant is monolithically connected to the fixation member at afirst frangible connection.
 5. The surgical implant system of claim 4,wherein the first frangible connection can be sheared throughapplication of torque applied to the fixation member.
 6. The surgicalimplant system of claim 2, wherein the implant is monolithicallyconnected to the insertion instrument at a second frangible connection.7. The surgical implant system of claim 6, wherein the second frangibleconnection can be broken through application of a force applied to theinsertion instrument.
 8. The surgical implant system of claim 2, whereinthe implant is one of spinal implant, a cortical plate, and anacetabular cup.
 9. The surgical implant system of claim 2, wherein thesurgical implant system is manufactured by 3D printing.
 10. The surgicalimplant system of claim 2, wherein the surgical implant system ismanufactured by additive layer manufacturing.
 11. A method ofmanufacturing a surgical implant system comprising: 3D printing thesurgical implant system to include an implant, a fixation member forsecuring the implant to tissue, and an insertion instrument, wherein theimplant is monolithically connected to the fixation member at a firstfrangible connection and the implant is monolithically connected to theinsertion instrument at a second frangible connection, such that theimplant, the fixation member, and the insertion instrument togethercomprise a single monolithic structure.
 12. The method of manufacturingof claim 11, wherein the step of 3D printing includes 3D printing thesurgical implant system of a single material.
 13. A method of insertinga surgical implant system comprising: implanting a single monolithicstructure including an implant, a fixation member for securing theimplant to tissue, and an insertion instrument, wherein the implant ismonolithically connected to the fixation member at a first frangibleconnection and the implant is monolithically connected to the insertioninstrument at a second frangible connection; applying a force to thefixation member to break the first frangible connection; and applying aforce to the insertion instrument to break the second frangibleconnection.